Quality Assurance

Analytical Laboratory Quality Assurance Policy

NEL is committed to providing analytical testing services and generating scientifically valid data of known and documented quality. All policies and procedures at NEL have been established to comply and adhere to NELAC, A2LA (2371.01) (2371.02) Accreditation, AIHA LAP, LLC (LAP-102960) Accreditation, State of Maine, and ISO 17025 standards.

It is the laboratory’s policy to conduct all projects in a timely manner using EPA, FDA, ASTM, AOAC, and other Standard Reference Methods as well as with state of the art technology/instrumentation.

NEL is also dedicated to good professional practice, communication with clients and to the quality of its testing and calibration. Any questions about the Analytical Departments Quality Program should be directed to the QA Officer (x302, x317).

Media Quality Control Statement

Northeast Laboratory Services produces and packages microbiological culture media at a facility inspected by the Food and Drug Administration for compliance with the current Good Manufacturing Practices regulations for Medical Devices and Diagnostic Products, CFR 21, Part 820.

Compliance with the CLSI Standard M22-A3, Quality Assurance for Commercially Prepared Microbiological Culture Media is a criterion for release of invitro diagnostic products. Products must meet the characteristics specified in the CLSI Standard before shipment release to your laboratory.

NEL also offers customized quality control testing. Product specific organisms and growth challenge levels are available to meet specific requirements, including procedures which follow USP recommended guidelines. Sterility confirmation testing with specified temperature and duration may also be designed to meet unusual needs.

All product testing is certified on product/lot specific certificates of analysis (COA), which are available for each manufactured lot.

Your satisfaction with our service and the quality of our products is the primary goal of the NEL staff. Any questions or concerns you may have regarding NEL products should be addressed to the Quality Assurance Department (X317) or our very friendly Customer Service Department (X304).